The Recall Desk
HighFDA (Devices)·Z-0864-2022·Announced 2022-04-13

Total Knee Surgical Kit Recall Due to Potential Sterility Breach

Stradis Medical is recalling 76 units of Total Knee Surgical Kits with potentially perforated or torn outer bags that may compromise sterility. Distribution occurred in Indiana, Texas, and Pennsylvania.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving potential sterility breach of surgical kit packaging. No illnesses or injuries have been reported; therefore, it qualifies as a risk-of-harm product where injury has not yet been reported, corresponding to severity level 3.

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling 76 units of Total Knee Packs (Surgical Kits). The affected product is identified by SKU/Part Number 570-2676 and UDI H65257026760. Affected lot numbers include: 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, and 22005482064.

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

The recalled kits were distributed in Indiana, Texas, and Pennsylvania.

The recalled product

Product
Total Knee Pack - Surgical Kit
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Kit
Hazard
  • sterility-breach
  • packaging-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • SKU/Part Number 570-2676
  • UDI H65257026760 Lot Numbers: 20156461673
  • 20171461909
  • 20174462304
  • 20239463246
  • 20342468026
  • 21130473544
  • 21286478854
  • 21326479944
  • 22005482064

Distribution

Distributed nationwide across the United States.

Related recalls

Same category